Kornimate/medical-research-clean huggingface dataset:
fatmax exercise in menstrual phases: effects on fat metabolism & body composition in nwo women

Conditions: Fat Metabolism

Summary: effects of a fatmax exercise intervention during different menstrual phases on fat metabolism and body composition in nwo women

this is a randomized clinical trial of single-blind with 3 arms (control group , follicular group and luteal group), in which a pre-treatment-posttest design has been used.

Eligibility criteria:
inclusion criteria: * criteria: inclusion criteria: * female, aged between 18 and 30 years old; * bmi between 18.5 and 24.9 kg/m2 with a bf% \> 30% (normal weight obesity determination criteria); * regular menstrual cycles for at least 3 months; * no use of oral contraceptives for at least 6 months before the experiment; * non-smoker and non-alcohol abuser. exclusion criteria: * the presence of cvd; * a diagnosis of cancer, pulmonary diseases, or other conditions that prevent participation in exercise; * the use of medications affecting body composition or metabolism.

Keywords: aerobic exercise menstrual cycle phase normal weight obesity lipid metabolism
fibrinolytic therapy versus medical thoracoscopy

Conditions: Pleural Diseases

Summary: the purpose of this prospective randomized clinical trial is to compare two currently accepted standard-of-care treatment strategies: medical thoracoscopy as compared to instillation of intrapleural tissue plasminogen activator (tpa) and human recombinant deoxyribonuclease (dnase) for the management of complicated pleural infections in adults as defined as complicated parapneumonic effusions or pleural empyema.

pleural infection (empyema or complex parapneumonic effusion \[cppe\]) represents one of the common clinical diagnoses encountered in clinical practice in the united states (us) and worldwide. the incidence of pleural infection continues to rise with an annual incidence of approximately 65,000 in the us and united kingdom (uk). it is associated with substantial morbidity and mortality as well as increased hospital costs despite advances in medical diagnostic and therapeutic strategies. the overall mortality of pleural infection approaches 20% and it is above 30% in elderly patients over 65 years and immunocompromised patients. treatment of cppe or empyema requires antibiotics and drainage of the pleural cavity.3 however, in about 30% of cases, it is difficult to remove the fluid due to loculations, septations and increased viscosity of the pleural fluid, and around 20% will need surgical intervention to adequately treat the pleural infection. specific aim 1: to compare the efficacy of early medical thoracoscopy versus fibrinolytic therapy (tpa/dnase) in patients with complicated parapneumonic effusions or pleural empyema. cppe is defined as non-purulent effusion in a patient with clinical evidence of infection such as fever and/or elevated blood leukocyte count and/or elevated crp, with pleural fluid ph ≤ 7.2 (measured by blood-gas analyzer), or pleural fluid glucose \ 1000 iu/l26. empyema is defined as pus within the pleural space and/or presence of bacteria on pleural fluid gram stain or culture. for patients to be considered for the trial they need to fulfill one of the following criteria: 1) cppe along with evidence of septated pleural effusion on pleural ultrasonography and/or chest ct scan or 2) empyema.

Eligibility criteria:
inclusion criteria: 1. cppe along with evidence of septated pleural effusion on pleural ultrasonography and/or chest ct scan 2. empyema. exclusion criteria: 1. age \<18 years; 2. pregnancy 3. inability to give informed written consent; 4. previous thoracic surgery or thrombolytic therapy for pleural infection; 5. medical thoracoscopy cannot be performed within 48 hours; 6. inability to tolerate procedure due to hemodynamic instability or severe hypoxemia; 7. inability to correct coagulopathy; 8. presence of a homogeneously echogenic effusion on pleural us27 -
cupping in fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this randomized controlled study is to determine the effectiveness of cupping in patients with fibromyalgia compared to sham cupping.

see above

Eligibility criteria:
inclusion criteria: * fms diagnosis according to awmf guidelines, * necessary documents: medical records * pain intensity \> 45mm vas * participation in cupping twice weekly on appointment exclusion criteria: * pregnancy * other study participation * pain due to other rheumatic disease * major psychiatric disorder * substance abuse * severe somatic disorder (cancer) * injections, acupuncture, neural therapy within the past 3 months

Keywords: fibromyalgia cupping
nasha/dx as a perianal implant for the treatment of persistent fecal incontience after anorectal malformation

Conditions: Fecal Incontinence; Anorectal Malformation

Summary: persistent fecal incontinence (fi) after anorectal malformations (arm) is a common occurence. during the last two decades perianal injection therapy has emerged as an option for treating patients with fi due to other causes than arms. the studies done on different implants have always expempted patients with arm which has led to arm being a formal contraindication for treatment with perianal injection therapy. the study aims to treat patients with persistent fi after arm with perianal injection of nasha/dx (solesta®) and follow them with clinical examination and questionnaires up to 18 months post treatment.


Eligibility criteria:
inclusion criteria: * persistent fi (miller incontinence score \>5) * anorectal malformation. exclusion criteria: * pregnancy * rectal prolapse * significant mucosal prolapse * inflammatory bowel disease * anorectal surgery within the last year before inclusion * anticoagulant medication/bleeding diathesis * anorectal sepsis in the past * immunodeficiency * immunosuppressing therapy

Keywords: fecal incontinence anorectal malformation
consitution of a biological collection from samples from the gut microbiote in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine

Conditions: Bone and Joint Infection

Summary: optimal surgical therapy (debridement in chronic osteomyelitis; device exchange in patients with chronic prosthetic joint infection \[pji\]) could be sometimes non-feasible, especially in the elderly population. therefore, a medical therapy with oral prolonged suppressive antibiotic therapy (psat) seems to be an option to prevent recurrence and prosthesis loosening. unfortunately, some patients are infected with resistant pathogens for which oral antibiotics are not suitable. subcutaneous (sc) administration of injectable intravenous antibiotics as psat could be a convenient way to limit catheter-related complications and facilitate ambulatory care. however, there are few data concerning the development of resistance under subcutaneous prolonged treatment with betalactamine. the aim of this study is is just to constitute a biological collection from samples from the gut microbiote in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. later analysis will be led on those samples to detect the acquisition of resistance or not.


Eligibility criteria:
inclusion criteria: * patients having an ostéo-articular infection (on material or on native bone) and having an indication of antibiotic treatment suppressive subcutaneous by betalactamine and managed at the croix-rousse hospital * patients not opposed to participate to the study exclusion criteria: * none

Keywords: gut microbiote, bone and joint infection, antibiotics
a 2 part, phase 2 trial of galeterone in the treatment of castration resistant prostate cancer

Conditions: Prostate Cancer

Summary: a phase 2, 2 part trial to evaluate the safety and efficacy of galeterone in castration resistant prostate cancer (crpc) patients.

this trial will be split into two parts. the purpose of part 1 will be to confirm dose and target patient population and part 2 will be expansion of the dose and patient population selected in part 1. for eligible patients, there will be an optional extension dosing following the completion of part 1 or part 2 of the trial. obtaining of informed consent and screening may be performed up to 28 days prior to enrollment. each patient will be able to receive his specified regimen for 3 consecutive cycles. each cycle consists of 28 days (approximately 1 mo.). end of cycle 3 visit assessments will be used to determine outcome and dosing may continue up to an additional 2 weeks until the results of all assessments are obtained. eligible patients may continue treatment in an optional extension period following the completion of the primary parts of this trial.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed adenocarcinoma of the prostate 2. ongoing androgen blockade demonstrated by serum testosterone concentration of less than 50 ng/dl 3. demonstration of progression while on androgen blockade 4. eastern cooperative oncology group (ecog) performance status \<2 exclusion criteria: 1. depending upon patient prior treatment the following apply: * prior treatment with cyp17 inhibitors or ar antagonists (e.g. abiraterone, tak-700, arn-509, ketoconazole\*, enzalutamide, or galeterone) - treatment naïve only * prior treatment with cyp17 inhibitors (e.g. tak-700, ketoconazole\*) or ar antagonists (e.g. enzalutamide, arn-509,) or galeterone - abiraterone refractory only * prior treatment with cyp17 inhibitors (e.g. abiraterone, tak-700, ketoconazole\*) or ar antagonists (e.g. arn -509) or galeterone - enzalutamide refractory only 2. prior chemotherapy (unless allowed for some study arms) 3. treatment with non-steroidal oral antiandrogens within 4 weeks of enrollment 4. prior use of any chronic systemic glucocorticoids . 5. prior radiation therapy within 3 weeks and radionuclide therapy within 8 weeks of enrollment 6. prior treatment with alpharadin® (xofigo®) 7. treatment with anti arrhythmia therapy for ventricular arrhythmia \< 4 weeks prior to enrollment 8. treatment with coumadin® or other anti-coagulant therapy (except aspirin) \< 4 weeks prior to enrollment 9. severe systemic diseases or active uncontrolled illnesses. 10. abnormal heart function 11. liver metastases 12. brain metastases (unless stable disease \>3 mos. by scan without additional cns-directed therapy) 13. the patient has known allergy to any of the treatment components 14. any physical or mental condition or social situation that in the opinion of the investigator may interfere with the patient's ability to comply with the trial procedures 15. history of excessive alcohol consumption 16. use of any substance known to cause ame

Keywords: prostate cancer crpc
expanded access use of sulopenem etzadroxil/probenecid for complicated urinary tract infection

Conditions: Complicated Urinary Tract Infection; Acute Pyelonephritis

Summary: sulopenem etzadroxil/probenecid is available to clinicians through an expanded access program for the treatment of complicated urinary tract infections due to quinolone nonsusceptible uropathogens after an initial course of effective intravenous therapy. the investigational product may be requested by sending an email to the sponsor (eaprogram@iterumtx.com), as listed on the reagan udall eap navigator website (https://navigator.reaganudall.org/company-directory/i).

this expanded access program will allow clinicians to use sulopenem etzadroxil/probenecid for the treatment of patients with serious or immediately life-threatening complicated urinary tract infection due to quinolone-nonsusceptible uropathogens where there are no satisfactory oral alternatives to use as step-down therapy after receiving an initial course of effective intravenous therapy. the recommended dose of sulopenem etzadroxil/probenecid 500 mg/ 500 mg is one bilayer tablet orally twice daily, taken with food whenever possible. no dose adjustment is required for patients with renal impairment. duration of therapy will be at the discretion of the prescribing clinician, depending on the type of infection being treated and the response to therapy, and is expected to be less than ten days total.

Eligibility criteria:
inclusion criteria: 1. adults ≥18 years of age with complicated urinary tract infection due to a quinolone-nonsusceptible uropathogen 2. patient or the patient's legally acceptable representative able to provide a signed written informed consent prior to any study-specific procedures. 3. clinically documented pyelonephritis or complicated urinary tract infection for which at least one dose of effective intravenous antibiotics has been received. exclusion criteria: 1. patients who require concomitant administration of valproic acid 2. patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial drugs or probenecid. 3. patients with known uric acid kidney stones 4. patients requiring concomitant use of ketorolac tromethamine or ketoprofen
oral enteral nutrition in infants with cerebral palsy and dysphagia

Conditions: Cerebral Palsy

Summary: this was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. the participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding , n=40). nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared.

the efficacy of persistent nasogastric tube feeding is not sufficiently satisfactory, necessitating the exploration for a more effective and safe nutrition support approach. therefore, this study reports the clinical effect of intermittent oro-esophageal tube feeding compared to persistent nasogastric tube feeding in the infants with cerebral palsy and dysphagia who received systemic therapy. method this was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. the participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding, n=40). nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared.

Eligibility criteria:
inclusion criteria: * meeting the diagnostic criteria of cerebral palsy. * age\<1 year; * diagnosed as dysphagia confirmed by dysphagia disorder survey or pediatric esophagoscopy; * with a nasogastric tube inserted at admission; * enteral nutrition support is required and feasible. exclusion criteria: * with dysphagia caused by other diseases or factors; * with progressive neurological disease or degenerative neurological disease; * with severe heart disease, liver or kidney dysfunction, hematological disorders, or other acute and severe symptoms; * with abnormalities in the oral cavity, pharynx, esophagus, or other parts of the digestive tract; * with poor compliance.
direct comparison of altered states of consciousness induced by lsd, psilocybin, and dmt in healthy participants

Conditions: Healthy

Summary: the primary objective of this study is to determine whether equivalent moderately high doses of lsd, psilocybin, and dmt produce qualitatively similar peak effects when the effect duration is standardized with ketanserin. a dmt infusion mimicking oral lsd and psilocybin administrations will be tested, as well as intravenously administered ketanserin.

lysergic acid diethylamide (lsd), psilocybin, and n,n-dimethyltryptamine (dmt) are serotonergic hallucinogens (psychedelics) and currently investigated as therapeutic tools for the treatment of various psychiatric disorders. they are usually administered in a dose range which induces an alteration of consciousness via the stimulation of the serotonin (5-ht)2a receptor. however, there are differences in the receptor activation profiles between the three substances that may induce different subjective effects. moreover, they exhibit different pharmacokinetic qualities. in comparative studies of lsd and psilocybin blinding was impaired by the different duration of subjective effects. this study aims to ensure blinding by ending all experiences at the same time with the 5ht2a antagonist ketanserin. moreover, no study has yet directly compared dmt to lsd and psilocybin. the dmt infusion will be modeled in accordance with the course of an oral lsd and psilocybin administration. therefore, the lpd-study compares the acute and subacute effects of lsd, psilocybin, and dmt while standardizing the time course and the duration of action for all substances.

Eligibility criteria:
inclusion criteria: 1. good understanding of the german language 2. understanding of procedures and risks associated with the study 3. willing to adhere to the protocol and signing of the consent form 4. willing to refrain from the consumption of illicit psychoactive substances during the study 5. willing not to operate heavy machinery within 48 h after administration of a study substance 6. willing to use effective birth control throughout study participation 7. body mass index 17 - 34.9 kg/m2 exclusion criteria: 1. relevant chronic or acute medical condition 2. current or previous major psychiatric disorder (e.g. psychotic disorder) 3. psychotic disorder or bipolar disorder in first-degree relatives 4. hypertension (sbp\>140/90 mmhg) or hypotension (sbp\<85 mmhg) 5. bradycardia (\< 45 bpm) 6. prolonged qtc interval (males: \>450 ms, females: \>470 ms) 7. av block ii° (mobitz type and webckebach type) and iii° 8. hallucinogenic substance use (not including cannabis) more than 20 times or any time within the previous two months 9. pregnancy or current breastfeeding 10. participation in another clinical trial (currently or within the last 30 days) 11. use of medication that may interfere with the effects of the study medication 12. tobacco smoking (\>10 cigarettes/day) 13. excessive consumption of alcoholic beverages (\>15 drinks/week)

Keywords: psychedelics lsd psilocybin dmt
blood pressure first medication therapy management

Conditions: Hypertension; Blood Pressure; Cardiovascular Diseases

Summary: the primary objective of this project is to improve the health status of participants through pharmacist-delivered blood pressure control programs that demonstrate value to employers and justify adoption, sustainability and scalability of these programs.

univariate comparisons of the baseline/pre-intervention outcomes to the post-intervention outcomes will be performed on outcomes in order to determine how the intervention affects each. for continuous outcomes data the univariate comparisons of the pre-treatment and post-intervention outcomes will be performed using related samples t-test comparisons. for categorical outcomes data, comparisons of pre-intervention to post-intervention time frames will be performed using mcnemar tests.

Eligibility criteria:
inclusion criteria: * all health plan beneficiaries 18 years-of-age and older * have filled at least one blood pressure medication in the last three months, * have a known hypertension diagnosis or have an uncontrolled blood pressure exclusion criteria: * not an adult * not a health plan beneficiary of the self-insured employer * not ambulatory and able to work or participate in care visits
development and evaluation of 'my voice': a randomized controlled trial

Conditions: Advance Care Planning; Heart Failure

Summary: the study aims to develop and evaluate a web-based interactive platform (called 'my voice') that helps to educate patients with heart failure and their caregivers about heart failure, identify their goals for end-of-life care, and share these with their caregivers and doctors.

the research study consists of 3 phases: 1. usability testing - to assess the usability of 'my voice' with patients with heart failure, their caregivers and healthcare providers, 2. pilot testing - to test the feasibility of implementation and workflow of 'my voice' and the survey questionnaires with a small group of participants and, 3. randomized controlled trial- to evaluate the effectiveness of 'my voice' with a control group who do not receive the intervention in improving patient outcomes

Eligibility criteria:
inclusion criteria: - the inclusion criteria for patients are 1. age ≥ 21 years old 2. singaporean or permanent resident 3. diagnosed with heart failure 4. symptoms classified under nyha class ii (with an ejection fraction of less than or equal to 35%), iii or iv 5. intact cognition determined through the abbreviated mental test (amt) (for pilot testing and main rct) 6. ability to speak and read english, mandarin or malay 7. willing to complete a web intervention 8. easily contactable via mobile phone or landline 9. have a permanent address in singapore for at least the next 1 year 10. not recruited in a previous phase of the study the inclusion criteria for caregivers are 1. age ≥ 21 years old 2. nominated as a healthcare spokesperson by the patient or the main decision maker for the patient (for intervention arm only) 3. ability to speak and read english, mandarin or malay 4. willing to complete a web intervention 5. easily contactable via mobile phone or landline 6. have a permanent address in singapore for at least the next 1 year exclusion criteria for caregivers are: a) domestic helper
wheat bioactives and immune function

Conditions: Endocrine, Nutritional, Metabolic and Immunity Disorders

Summary: the purpose of this research was to understand the effects of bioactive compounds found in wheat cereal on human immunity. subjects came in for a baseline blood draw, consumed whole wheat bran cereal daily for 21 days, and returned for a final blood draw. immune function assays were performed at both sampling times. it was predicted that eating wheat bran would benefit immune function.

healthy individuals, between 18 and 50 years of age, were recruited by flyer and word of mouth on the university of florida campus and in the surrounding area, in may of 2010. eligible subjects were randomly assigned to one of two experimental groups, to consume either 50 grams or 100 grams of whole wheat bran cereal daily, for three weeks. blood was drawn from fasting subjects before consumption (baseline) and after three weeks of cereal consumption. peripheral blood mononuclear cells (pbmc) were isolated and cultured with a broad based mitogen and autologous serum for 10 days. pbmc were stained with fluorochrome-conjugated antibodies on day 0 and day 10 of culture, at each blood draw. data was acquired by flow cytometry and analyzed. overall compliance was assessed using self-reported data and by counting left-over bags of cereal.

Eligibility criteria:
inclusion criteria: * generally healthy * aged 18-65 exclusion criteria: * chronic health problems * high blood pressure * bmi greater than 25 * vegan

Keywords: wheat bran healthy immunity t cells